Internal Fixation or Joint Replacement Therapy for Aged Hip Fracture Patients

Intertrochanteric Fractures Clinical Trial

Official title:

Internal Fixation or Joint Replacement Therapy for Hip Fracture Patients Over 75 Years Old Combined With Multiple Internal Medicine Complications: a Prospective, Multicenter, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03407131
• Other study ID #: PUPH20171228
• Status: Not yet recruiting
• Phase: N/A
• First received: January 11, 2018
• Last updated: January 21, 2018
• Start date: February 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: January 2018
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of internal fixation or arthroplasty for hip fracture patients over 75 years of age with multiple medical complications through the operation time, intraoperative bleeding, time to start weight bearing activities and other indicators.

Description:

Patients will be enrolled from five study centers, each center will be free with regard to surgical indications and postoperative prescription. The unstable fractures were A2 and A3 (31 A2.2 and 3, and 31 A3.3) according to the AO classification. The investigators will use a prospective randomized approach to determine the treatment procedure for patients. The patients undergoing arthroplasty will be regarded as the experimental group and the patients who accept the intramedullary nail fixation will be regarded as the positive control group. All patients will receive consistent anticoagulant, analgesic and other therapeutic measures in the perioperative period except for the different surgical methods. The two groups will be compared in age, sex, pre-fracture place of residence, fracture type and preoperative comorbidity. The investigators will evaluate the effect and safety of the two types of operations by comparing the surgical related data, complication incidence and functional rehabilitation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Intertrochanteric fractures of the femur need surgery

• Male and female, age more than 75 years old

• Combined with more than one medical complication, including hypertension, cerebral infarction, respiratory failure, renal insufficiency, coronary heart disease, diabetes, heart failure, pulmonary infection, heart rate, water and electrolyte disorders

• The patient is still able to tolerate surgery through the anaesthesia and related department assessment

• Signed written informed consent

Exclusion Criteria:

• No complications associated with internal medicine

• Mild fracture displacement and conservative treatment required

• Multiple trauma involving more than one organ system

• Known to have progressive malignant neoplasms

• It is not possible for the subjects to follow the test scheme, such as uncooperative attitudes, inability to return to the research centre for follow-up visits and inability to complete the study

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures

Intervention

Procedure:
• Joint replacement surgery
Joint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible.
• Intramedullary nail fixation
Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Peking

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding related index	Postoperative drainage volume and bleeding volume during operation(Unit: ml)	Three days after the operation
Secondary	Joint rehabilitation index	Early loading time	Three months after the operation
Secondary	Complication rate	The incidence of postoperative lung infection, urinary tract infection, bedsore and mortality	Three monthes after the operation
Secondary	Functional rehabilitation index	Harris Scores of the two groups	Three months after the operation
Secondary	Surgical related index	operation time of the two groups(Unit: minutes)	Three days after the operation